BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 20203024 · Received September 12, 2024

    Report

    Report Number
    1823260-2024-02637
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 14, 2024
    Report Date
    December 4, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    UDI-DI
    07613336121535
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER'S SERIAL NUMBER IS (B)(6). A SMALL AMOUNT OF PRECIPITATES WERE OBSERVED IN THE SAMPLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    QC OUTLIERS WERE OBSERVED AROUND THE DATE OF THE EVENT. THE CALIBRATION DATA THAT WAS PROVIDED (FOR DATES (B)(6) 2024) WAS ACCEPTABLE. A BUBBLE WAS OBSERVED ON TOP OF THE SURFACE FOR ONE OF THE SAMPLES. ON (B)(6) 2024, A SAMPLE PIPETTOR ERROR WAS OBSERVED WHICH IS CONSISTENT WITH A SAMPLE QUALITY ISSUE. THE FIELD SERVICE REPRESENTATIVE REPLACED THE PROBE AND SPRING, PERFORMED ALIGNMENTS, AND PRIMED THE SAMPLE TUBE. QC PASSED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.63 G/L. THE SAMPLE WAS REPEATED TWICE ON (B)(6) 2024, RESULTING IN VALUES OF 0.13 G/L AND 0.11 G/L. THE CUSTOMER REPEATED THE SAMPLE BECAUSE A SECOND SAMPLE COLLECTED FROM THE PATIENT HAD VALUES SIMILAR TO THE REPEAT VALUES OBTAINED ON (B)(6) 2024. THE VALUES FROM THE SECOND SAMPLE WERE NOT PROVIDED. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AND WAS QUESTIONED BY THE CLINICAL STAFF. DUE TO THE RESULT BEING QUESTIONED BY THE CLINICAL STAFF, THE SAMPLE WAS REPEATED. AN AMENDED REPORT WAS SENT AS THE REPEATED RESULT MATCHED THE CLINICAL PICTURE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557863 TOTAL PROTEIN URINE/CSF GEN.3 URINE/CSF TOTAL PROTEIN TEST JIQ ROCHE DIAGNOSTICS 783083 07613336121535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female